Sirnaomics, Inc. is a leading clinical stage biopharmaceutical company in the discovery and development of RNAi therapeutics for treatment of cancer and fibrotic diseases. We are seeking candidates to fill the newly created position of Document Writer (Regulatory Affairs) for our headquarters in Gaithersburg, MD.
The well-qualified candidate writes and manages documents to support regulatory submissions for projects in various stages of development and is involved in a variety of types of medical and technical writing, searching for and summarizing source information, formatting of documents, managing review and adjudication of comments from reviewers, quality control of documents, document management and archiving.
Requirements and Responsibilities
- Serve as day-to-day Regulatory Writer to achieve project goals for regulatory affairs activities.
- Collaborate with regulatory affairs staff to provide regulatory document management and control guidance in support of cross-functional teams.
- Develop and maintain a reference library for published literature, study reports and regulatory agency guidelines to support all projects.
- Assist in preparing regulatory support materials for teams for regulatory agency interactions, including PowerPoint presentations, speaker’s notes and other documents, as required.
- Prepare templates for, and QC documents for INDs, NDAs, CTAs, MAAs, annual reports, amendments and correspondence, in collaboration with regulatory affairs project leads.
- Provide document formatting, preparation, and quality assessment of documents for regulatory submissions
- Identify regulatory writing or document management issues proactively that may impact the assigned project(s) and discuss strategies to address them with the Head of Regulatory Affairs.
- Stay abreast of the requirements for writing and document management and control through active participation in conferences and training.
- Developing and maintaining templates, files and involved in maintenance of the electronic archive for regulatory documents.
- Provide advice to project team relating to writing or document control and management practices.
- Collaborate with regulatory affairs staff to develop functional area practices, policies, and procedures, facilitate their review and implementation of such documents.
Education & Experience
- Bachelors' degree or equivalent in a related field.
- Eight or more years of experience in the pharmaceutical or biopharmaceutical industries to include five or more years of experience participating in or independently preparing and writing medical/technical documents, filings and similar items relating to regulatory affairs and/or regulatory operations.
- Excellent communication, verbal and written skills and familiarity with the requirements and etiquette of telephone and video conferences.
- Robust word processing skills for example: WORD, Excel, PDF, PowerPoint, software for designs, schematics and flow diagrams, literature searching, literature reference and study report management tools, document organization and document management skills.
- Familiarity with Accenture Starting Point Templates is preferred.
- Demonstrated knowledge of and ability to interpret regulatory requirements and guidelines as well as familiarity with regulatory agency websites.
- Flexibility and adaptability in order to take on new, unexpected or urgent activities, as required.
- High level of interest in continuing learning in order to develop knowledge and new professional skills.
Sirnaomics, Inc. is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender-identity, national origin, disability status, protected veteran status, genetic characteristics or any other characteristic protected by law.